VANCOUVER, January 31, 2018 – Aequus Pharmaceuticals Inc. (TSX-V: AQS, OTCQB: AQSZF) (“Aequus” or the “Company”), a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today announced plans to advance its transdermal patch for pregnancy-related anti-nausea, AQS1303, following positive results from the proof of concept study completed in 2017. The Company will work with its regulatory and strategic consulting partner, Camargo Pharmaceutical Services, LLC (“Camargo”), to prepare for a pre-Investigational New Drug Application (“pre-IND”) meeting with the US Food and Drug Administration (“FDA”) to define the clinical strategy for approval in the United States. The Company anticipates pursuing an abbreviated 505(b)(2) pathway.
“We feel very strongly about the need for this program and are delighted to see its continued progress,” said Anne Stevens, COO and Director of Aequus. “We expect a meeting with the FDA in the second quarter of this year and anticipate it will provide clarity on the requirements for AQS1303 in order to achieve FDA approval under 505(b)(2).”
AQS1303 is a long-acting transdermal patch intended for the treatment of nausea and vomiting of pregnancy (“NVP”). AQS1303 would provide patients with a more convenient and reliable delivery system as an alternative to the currently marketed oral form, which is dosed up to four times per day. Currently, the oral form of Diclegis ® is the only FDA-approved medication for morning sickness in pregnant women and in 2015 reached sales in the United States of approximately U.S.$120 million, according to IMS data. It is estimated that 70% of women experience NVP, and in some severe cases it may persist throughout their entire pregnancy, having a significant impact on expectant mothers’ quality of life. A long-acting transdermal form of pyridoxine/doxylamine is being developed by Aequus to address the risk of missed doses due to emesis (vomiting) and to provide consistent and sustained symptomatic relief.
Aequus owns global rights to this program.
Aequus has advanced the multi-day transdermal patch, AQS1303, containing the combination of pyridoxine hydrochloride and doxylamine succinate (the active ingredients in Diclegis ®/Diclectin ®) through an initial Proof of Concept clinical study, completed in September 2017. The Proof of Concept study was a single-dose cross-over comparative bioavailability study versus the currently approved oral version, Diclegis ®/Diclectin ®, and was successfully completed in nine healthy female volunteers. The results suggested that sustained delivery of therapeutic levels of the active ingredients through the skin over a multi-day period is possible with the current formulation. The formulation was well tolerated with no serious adverse events reported.
This product is expected to follow a Section 505(b)(2) New Drug Application (NDA), an abbreviated clinical pathway in which the FDA would allow for the Company to reference safety and efficacy data of the original oral tablet form of the medication.
ABOUT AEQUUS PHARMACEUTICALS INC.
Aequus Pharmaceuticals Inc. (TSX-V:AQS, OTCQB:AQSZF) is a growing specialty pharmaceutical company focused on developing and commercializing high quality, differentiated products. Aequus’ development stage pipeline includes several products in neurology and psychiatry with a goal of addressing the need for improved medication adherence through enhanced delivery systems. With a focus in neurology and other specialty areas, our most recent addition to the development pipeline was a long-acting form of medical cannabis, where there is a high need for a consistent, predictable and pharmaceutical-grade delivery of products for patients. Aequus intends to commercialize its internal programs in Canada alongside its current portfolio of marketed established medicines and will look to form strategic partnerships that would maximize the reach of its product candidates worldwide. Aequus plans to build on its Canadian commercial platform through the launch of additional products that are either created internally or brought in through an acquisition or license; remaining focused on highly specialized therapeutic areas. For further information, please visit www.aequuspharma.ca.
ABOUT CAMARGO PHARMACEUTICAL SERVICES, LLC.
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com